ePI Readiness & Strategy
Know exactly where you stand on the EMA ePI mandate before deadlines force costly decisions. A focused 4+ week advisory engagement to assess FHIR ePI and EMA ePI readiness, identify compliance gaps, define a clear conversion roadmap, and deliver a platform architecture recommendation – delivered by the team actively contributing to writing the HL7 Vulcan ePI Implementation Guide.
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Our ePI Readiness & Strategy Services
ePI Advisory
Expert advisory on ePI standards, regulatory requirements, and implementation strategy – giving your regulatory team the domain knowledge to make the right compliance decisions with confidence.
ePI Readiness Assessment
Your full labelling infrastructure is evaluated for FHIR ePI readiness across regulatory, IT, and data dimensions – every compliance gap mapped against the HL7 Vulcan ePI IG and applicable country-specific requirements, classified by severity, product category, and mandate deadline – delivered as one integrated roadmap.
ePI Pathfinder
A scoped conversion of one real label to FHIR ePI – validating your conversion path, tooling, HL7 Vulcan conformance, and regulatory acceptability before full programme commitment. Includes a regulatory team walkthrough and portfolio effort extrapolation, giving you both technical proof and a business case for programme approval.
ePI Migration Roadmap
A prioritized conversion roadmap sequenced by mandate deadlines -vaccines first, oncology next – covering resource requirements, milestones, and risk flags for every product category. Built directly from ePI Pathfinder pilot data and gap analysis findings, not generic templates. Structured for immediate handoff to your programme team.
ePI Platform Architecture Assessment
Architecture-first assessment of your infrastructure – cloud or on-premises – covering platform selection, GxP compliance architecture, regulatory data integration, and validation readiness for FHIR ePI at enterprise scale. Deep Azure expertise for confident delivery – recommendation fits your environment before the platform decision is made.
Capabilities
HL7 Vulcan ePI Working Group Member
As an HL7 Vulcan ePI Working Group contributor, we help write the standard your ePI must conform to – every engagement aligned as it develops and validated against your specific regulatory requirements.
ePI Platform
We catalogue and score your full label estate – Word, PDF, SPL, IDMP – by conversion complexity and market, giving leadership a data-driven basis for investment.
Confident ePI Compliance Starts with the Right Readiness Assessment
Benefits
Why Deevita
Our ePI Readiness Solutions
Readiness Assessment Report
A complete assessment of your existing label portfolio – across all source formats – identifying every compliance gap classified by severity and mandate deadline, with team readiness ratings across regulatory, IT, and data functions. Delivered as a single actionable report with clear priorities for your conversion programme.
ePI Accelerators
Ready to use accelerators to fasten the migration of pharmaceutical labels – Word, PDF, SPL, and IDMP – to FHIR ePI resources with a GxP-compliant audit trail on every conversion event.
ePI Platform
End-to-end ePI lifecycle management – from structured authoring and FHIR ePI conversion through submission, version control, and label change management. AI-assisted translation, compliance checking, and content extraction are embedded throughout. Multi-market compliance monitoring and analytics ensure ongoing regulatory alignment across all jurisdictions.
ePI Readiness & Strategy Use Cases
Migrate Legacy Labels to FHIR ePI
Life Sciences – Pharma Manufacturer
Problem
A pharma manufacturer holds product information across multiple legacy formats with no FHIR ePI conversion path and no internal ePI expertise. The Q3 2026 vaccine mandate deadline is approaching with no readiness assessment or conversion programme in place.
Solution
Deevita assesses the full label estate and compliance gaps, runs an ePI Pathfinder pilot to prove the conversion path on one real label, and delivers an HL7 Vulcan-aligned migration roadmap sequenced by mandate deadline and product category.
Impact
Azure Architecture Review for ePI
Life Sciences – Global Pharma Manufacturer
Problem
A global pharma manufacturer needs to determine what changes its existing Azure infrastructure requires to support a FHIR ePI data layer at an enterprise scale. The team has no clear view of FHIR ePI readiness, GxP compliance posture, or remediation effort before committing to a conversion programme.
Solution
Deevita conducts an architecture-first assessment of the existing Azure environment against FHIR ePI requirements, GxP compliance standards, and HL7 Vulcan EPI IG specifications – delivering a target-state Azure Health Data Services architecture and a prioritized remediation roadmap calibrated to the manufacturer’s environment, not a generic reference design.
Impact
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